Actively Recruiting

Phase Not Applicable
Age: 25Years - 55Years
All Genders
Healthy Volunteers
NCT05933707

Small Extracellular Vesicles and Insulin Action

Led by Washington University School of Medicine · Updated on 2025-07-17

72

Participants Needed

1

Research Sites

325 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goals of this research study are to: 1) understand why some people with obesity are protected from developing conditions such as type 2 diabetes and cardiovascular disease while others are more likely to develop obesity-related conditions; 2) assess the effect of small extracellular vesicles (sEVs also called exosomes), obtained from human participants, on metabolic function in cultured cells and in mice.

CONDITIONS

Official Title

Small Extracellular Vesicles and Insulin Action

Who Can Participate

Age: 25Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Metabolically healthy lean subjects must have a BMI 2.5 and 4.9 kg/m2
  • Subjects with obesity must have a BMI 0.0 and 5.0 kg/m2
  • Metabolically healthy lean and people with metabolically healthy obesity must have intrahepatic triglyceride content 5%
  • Fasting plasma glucose concentration less than 100 mg/dl
  • 2-hour oral glucose tolerance plasma glucose concentration less than 140 mg/dl
  • Hemoglobin A1C (HbA1c) 5.6% or less
  • HOMA-IR less than 2.5 for metabolically healthy lean and metabolically healthy obesity
  • People with metabolically unhealthy obesity must have intrahepatic triglyceride content 5.6% or higher
  • People with metabolically unhealthy obesity must have HOMA-IR 2.5 or higher
  • People with metabolically unhealthy obesity must have HbA1c between 5.7% and 6.4%, or fasting plasma glucose 100 mg/dl or higher, or 2-hour oral glucose tolerance test plasma glucose concentration 140 mg/dl or higher
Not Eligible

You will not qualify if you...

  • History of diabetes
  • History of liver disease other than nonalcoholic fatty liver disease
  • History of other serious diseases
  • Consume excessive amounts of alcohol (more than 21 units/week for men and more than 14 units/week for women)
  • Take medications that could affect the study outcome measures
  • Engage in regular exercise more than 120 minutes per week
  • Are pregnant or lactating

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

K

Kyle Timmons

CONTACT

B

Beth Henk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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